Episode Transcript
[00:00:00] Speaker A: Welcome to the Heart Rate Variability Podcast. Each week we talk about heart rate variability and how it can be used to improve your overall health and wellness.
Please consider the information in this podcast for your informational use and not medical advice. Please see your medical provider to apply any of the strategies outlined in this episode. Heart Rate Variability Podcast is a production of Optimal LLC and Optimal HRV. Check us out at optimalhrv.com Please enjoy the show.
Welcome friends to Heart Rate Variability Podcast. I am Matt Bennett and I am here with a return guest, Dr. David Eddy.
Dr. Eddy had a previous episode which if you haven't listened to that one, you know I would actually go back and listen to that to learn about Dr. Zeddi's journey with heart rate variability.
We're going to touch on, you know, substance use disorder here and I know we, we talked about that in the last episode as well. So really encourage you that because today we are going to jump in to one of those research articles is somebody who probably obsessively, maybe more than any person else in the world obsesses over HRV research.
There are certain articles that generate secondary press and when I say that some articles I think in grad school. Dr. Eddy, I was told that if you, if you published article in a journey journal, 10 people will read it if five of those are your family.
So that was always like wow, this is spectacular news to hear.
But there's other articles that you see this in the research is people take these in the hospital systems, healthcare systems, bloggers.
Really these key articles kind of catch like wildfire. And this is what's happened with your work. Whether you know it or not. It is having a nice effect wide. So before we nerd out about your most recent work, just give us a quick introduction of you and a little bit about, you know, your past work.
[00:02:12] Speaker B: Sure things. Thanks for having me back. I'm David Eddy. I'm a clinical psychologist at Massachusetts General Hospital and the associate director of Clinical translational Recovery science at the Recovery Research Institute at Mass General where we do a lot of important recovery related addiction recovery related research and I'm an assistant professor at Harvard Medical School as well.
[00:02:36] Speaker A: Awesome. So the article is titled heart Rate Variability Biofeedback for Substance Use Disorder A randomized trial just just I believe published officially this month. October 1st is the the timestamp I had on it. So I was looking for hey, what research is out there for the this week in HRV episodes we started doing. I'm like not not only found this one like absolutely powerful research but, you know, a friend of the show as the lead author. So I'm excited to have you back. Let's just maybe get a little bit of background. I know this fits well into your previous work, but what was sort of the genesis behind, you know, a randomized clinical trial which is, you know, a step up from, you know, a feasibility study or other things that you often see in the research?
[00:03:27] Speaker B: Right. Well, I, you know, I've been studying heart rate variability, biofeedback as an intervention for a number of years.
And for those who are not familiar, I'm sure most of your listeners are, but for those who aren't, so breathing based intervention where we train people using biofeedback to breathe at special frequencies, that affects really big changes in the autonomic nervous system. And this has, we've, we've found downstream benefits in terms of improving mental health stress management.
One of the key findings I found over and over in early pilot studies of HIV biofeedback for substance use disorder is it can reduce craving as well and anxiety and stress. And we always hypothesize that that would probably translate into better substance use outcomes for folks in early recovery who have an abstinence goal, perhaps, or at least the goal of reducing their alcohol or other drug use.
If we're managing stress, their cravings, their anxiety, we hypothesized that would translate into better substance use outcomes. But we didn't really have that data. All the previous clinical trials we did were very small. They were pilot studies. We weren't really able to follow folks afterwards for one reason or another.
We didn't have a lot of substance use outcomes that we could look at in this study. I really wanted to extend that work with a phase 2 clinical trial. So the pilot studies that already established safety, you know, there's preliminary signal of efficacy, there's definitely a signal that there's something going on here. There's probably, it seems like there's some benefit. So in a phase two trial, you know, we want to sort of, you know, use a bigger sample, expand the net a little wider, start to really test efficacy.
And also in this phase two, I really wanted to not just look at craving and negative affect, like stress, craving, anxiety. I also wanted to see if, you know, what we were seeing in previous study, those benefits in terms of reductions in negative emotionality, negative is actually translating into better substance use outcomes. And so in this study, we looked at that other stuff as well. But we also, it was really important to us to look at substance use outcomes as well. Which we did.
[00:05:47] Speaker A: Yeah. And so I, I almost have as many questions of this study with the control group that, that was also like some fascinating. Usually the control group's just boring, but you know, some of these findings. So I, I'd love to just kind of talk a little bit about how you, you know, just generally set, set up the study, the control group, you know, really well done from my perspective, but just kind of talk about what the study and what the participants of the study sort of did. Both the experimental and control group.
[00:06:23] Speaker B: Right, right.
We really think about HIV biofeedback as having its most utility as an addendum to existing first line treatments. So I've never really thought about HIV biofeedback as replacing cognitive behavioral therapy or medications. And I've always thought about it as an add on tool that could really, it could cover some of the biolog vulnerabilities of addiction and addiction recovery that are not covered by other treatments. But I never really thought about it as a replacement.
[00:06:53] Speaker A: Right.
[00:06:54] Speaker B: So in this study what we wanted to do is we wanted to add HIV biofeedback to treatment as usual.
[00:07:01] Speaker A: Yes.
[00:07:02] Speaker B: And then compare that to treatment as usual only. So in this way, sort of the study would have what we would call ecological validity. It would sort of map onto sort of how people would probably use this in the real world. Under real world conditions.
[00:07:15] Speaker A: Yes.
[00:07:16] Speaker B: And so we recruited a sample of people, about 120 people to begin with and we randomized them to either HIV by feedback plus treatment as usual or treatment as usual only. So for the treatment as usual part, folks were just told, keep doing what you're doing.
[00:07:35] Speaker A: Right.
[00:07:35] Speaker B: Like you go into mutual help meetings, keep doing that, doing individual therapy, do that, do your groups, do your medication, whatever you're doing, like just, just keep what you're doing.
Because we know in reality people in addiction recovery often doing multiple things.
[00:07:50] Speaker A: Right, exactly.
[00:07:51] Speaker B: And we encourage that, you know, clinically. Like, you know, I tell, I'm a clinical psychologist and I, I tell my patients like, you know, you don't have to do mutual help programs, but like if it feels like that's a fit for you, great. Add that on. Let's do that in addition to your psychotherapy with me. You know, like it's, there's, none of these things are contraindicated. There's just sort of cumulative benefit generally folks.
And so we wanted the study to have ecological validity. We wanted it to sort of track with how people would use it in the real world.
Now being a phase two trial, it wasn't really appropriate to be testing it against a standalone first line intervention like cbt. That's something you would do in a phase three trial.
Assuming the phase two trial points to efficacy, there's a signal of benefit and that's really the phase 1, 2, 3 model. This comes from drug and device development in the research world.
Cancer trials, for instance. You may have heard about phase two, phase three cancer trials. This is a standard progression of research that we utilize to reduce risk to participants and really bring the most rigor to testing and intervention. So at the end of the pipeline of the process, we really can say with a high degree of confidence whether something, you know is going to work or not. Right? For most people, most of the time, absolutely.
[00:09:20] Speaker A: So, so let's talk about the biofeedback intervention as part of this. What, what did that look like in, in this study?
[00:09:30] Speaker B: So one of the other things I really wanted to do in this study was to experiment with newer, what I call second generation HRV biofeedback technology and equipment.
So in my earlier studies we use more traditional first generation devices and approaches. So that meant we had some pretty expensive lab equipment, bring people into the clinic, into the lab. We'd hook them up to electrocardiogram respiration sensors and we would have them do biofeedback with a computer set up.
And that was great. And that was fine. We would have folks practice with handheld devices.
But you know, the thing I always concerned me was that, you know, limited the scalability, the potential for uptake of this intervention because like, you know, I mean, let's say for, you know, let's say that it works great, but then how many people are actually going to be able to access a provider who has this training, who has this equipment? Like it's not going to really have real world impact if people kind of access. And even if it's like the most effective treatment ever, if people can't access it, like, who cares, right?
[00:10:42] Speaker A: Exactly.
[00:10:44] Speaker B: But since we did those early pilot studies, some products are coming to the market that really allow for really high quality home practice without the need for a clinician.
And one of those products is the Leaf HIV biofeedback device which is out of the Bay Area.
It's a US based company founded by a guy formerly from mit.
And you know, I like this patch because it, well one, it's a patch, it's not a handheld device device, it's a wearable electrocardiogram device. The patch that you wear on your chest and it syncs with a smartphone app and it Affords ad libitum as needed practice. So folks wearing the patch can practice as many times a day as they like. And the app has a local interface and it's very intuitive. And there's sort of embedded trainings in the app. So you don't really need a clinician to learn to do this breathing practice. It's all sort of, which is really cool. But the other thing I really liked about that product when I was first exposed to it is it also works as adjust in time intervention. And folk researchers listening to this will probably be familiar with the idea of just in time interventions. But for those who aren't, it's just sort of this idea that we can have an intervention, often a digital therapeutic that can monitor our, you know, physiological states or, you know, emotional or effective states in the background passively and can provide some kind of prompt or intervention when risk is detected.
[00:12:26] Speaker A: Yeah.
[00:12:26] Speaker B: So the way this device does that is it monitors heart rate variability in the background using ecg.
So all day you're wearing this patch, it's passively monitoring your heart rate variability in the background. And then when your HIV drops in the absence of movement, which is often associated with stress response.
[00:12:45] Speaker A: Right, Right.
[00:12:46] Speaker B: Maybe for people with addiction craving, which is stressful, it prompts the wearer to do a quick burst of biofeedback.
[00:12:54] Speaker A: Great.
[00:12:54] Speaker B: One, two minutes to get HIV back up.
And so in that way it's kind of potentially getting out in front of the risk. Right. So, you know, if you're experiencing stress and stress is a risk factor for a relapse or elapsed to alcohol or other drug use, you're in early recovery from addiction. And that's like something you really don't. You know, it's not somewhere you don't want to be going, then you know, this device could get out in front of that risk potentially and tip people off in the moment, dial them in, as it were, to their stress days.
Which, you know, for what it's worth is like for folks in early recovery from addiction is a key vulnerability. Absolutely. Folks in the recovery from addiction, one of the hallmarks of that time period is sort of a lack of self awareness of affective states. This is like something well known to clinicians and it's a vulnerability. We try and plug in clinical care.
So what, you know, we have a device that can like signal to people in the moment. It's like, hey, you know, you may be aware that you're pretty stressed right now, but you're pretty stressed by the way. And like by the way, let's do a few minutes of paced breathing, get your physiology under control. And you know, maybe that gets you through to the next moment, you know, and you're less likely to pick up a drink to deal that stress.
[00:14:10] Speaker A: I love that. And so how long, you know, were you, what, how long was the intervention going? What was the study period where you, you had them, the two groups going.
[00:14:21] Speaker B: So, so we followed folks for eight weeks, and we chose eight weeks because, you know, you know, we've done shorter studies of, you know, three weeks of HIV biofeedback that have produced benefit.
The early protocols involved 12 weeks of biofeedback.
And so we were kind of looking for the sweet spot in the middle, trying to manage participant burden, thinking about sort of real world conditions like, you know, how long are people realistically going to be, want to do this for? And so we came to eight weeks. We felt like that was a reasonable place to start again. That's sort of an empirical question that we need to tease out in subsequent studies is like sort of what's the ideal amount?
But we settled on eight weeks. So we followed folks, we had folks in the biofeedback group do eight weeks of HIV biofeedback. We told them, like, you know, wear the device every day. You don't have to wear it all day. You're not sleeping with it on, you know, try, try and wear it most of the day when you're up and out, try and do 10 minutes of scheduled practice, 5 minutes, 5 minutes, 5 minutes in the morning, 5 minutes in the afternoon, and try and get in about 5 minutes of practice in response to the cues when the device is signaling, you know, like just in time, practice is indicated.
Or if you're just feeling stressed and maybe the device doesn't catch that, or you're having a craving and you're, you just need some help writing that, use it then as well. And we really, we wanted folks to do about 15 minutes of practice because we know from a previous pilot study that about 12 minutes of daily practice seemed to be the sweet spot for reducing anxiety. So we kind of studies around that. We knew 12 minutes was probably like an important threshold people needed to be at.
And so we wanted people hitting that so we kind of felt like they were getting a therapeutic dose.
[00:16:05] Speaker A: Yeah, because that's always the question that I hear different things about, what is that magical? And probably, you know, customers I talk to who are starting biofeedback, it's like, what is the magical number?
[00:16:18] Speaker B: What's the sweet spot?
[00:16:19] Speaker A: Right. You know, so that 12 is key because, you know, is it 20?
I've heard two doses of 20 minutes, which, and then everybody says nobody does those, you know, so it's like, yeah, we can, we can knock that out like it's 40 minutes, but nobody in the world will do it.
[00:16:39] Speaker B: Less is more.
[00:16:42] Speaker A: So it's a very, it's a very interesting metric to kind of chase it and try to figure out with that as well. So one of the interesting things, you know, as we get into the results, you know, I'll just read from, from the summary I got here. In contrast, the control group experienced increase in both negative affect and craving. So one of the things like that, that just kind of, even though I was like, you know, nerding out about the experimental group, this, this just kind of hit me like a ton of bricks of okay, I guess I'm left with the question. And you know, I always position HRV biofeedback, especially with the second generation devices that we're talking about is as homework, you know, as a size, like you said, a supplement.
What's going on with the control group, my friend? I just gotta ask because if they're getting treatment as usual, we would hope we would see improvement of symptoms in treatment as usual. But that's not what you found.
[00:17:49] Speaker B: Yeah, and of course, and of course there's a lot of variability in what people, how much treatment folks are engaged in.
[00:17:54] Speaker A: Right, right.
[00:17:54] Speaker B: And we wanted to have a naturalistic sample so we didn't tightly that.
[00:17:58] Speaker A: Yes.
[00:17:59] Speaker B: And of course, you know, like when we, we look at these trends, that's at the level of the mean, sort of on average as a group, you know, the, the control group was showing increases in negative affect which included stress and nervousness, anxiety and so symptoms of depression and, and craving.
That wasn't necessarily everybody's truth. I mean some, some folks in that group we saw reductions, but on the level of the meaning the group was showing increases. Whereas conversely, as you alluded to the experimental group, HIV biofeedback group, on average saw reductions over that time.
And I should add as well, you know, we didn't just sort of look at pre post levels of negative affect and craving. We were using ecological momentary assessment. We were surveying people twice a day using a smartphone app that would ping people twice a day and ask them like, rate your stress, rate your happiness, rate your nervousness, rate your craving. And so we had these really granular, repeated measures of affective states over the eight weeks. And so we were actually really to do some more sophisticated analyses and look at these sort of more sort of granular changes in negative affect over the course of the study. And that's really, that's an advance in clinical research and randomized controlled trials because it used to be we would just say give people a questionnaire baseline, then give them a questionnaire at the end of treatment, maybe over follow up. But we never really captured the ups and downs and the granularity of what was happening in treatment. Whereas with ecological momentary assessment we were really able to drill into that in a much more granular way and see these trends.
[00:19:45] Speaker A: I love that. So, so I'll, I'll let you knock out something that just popped into my head because it almost, it would almost seem like treatment as usual, you know, was causing more cravings and negative affects. So I appreciate what I'm going to say is wrong after this. But, but I mean logically if you just did the HRV biofeedback and didn't do anything else that you'd get better outcomes. I mean I kind of think I'm putting one in one together here without and I'm not encouraging by that's Trina Substance use disorder. Stop treatment. But yeah, but, but just like from a research perspective is is treatment as usual.
Is it? I, I don't know. Like you, I would not never want a client going through my treatments to experience, you know, increase cravings and negative increase in negative affects. So I just kind of wonder like I'm assuming you're not and I no way am I putting these words into your mouth because I wouldn't say them outside speculation.
What's going on here?
[00:20:55] Speaker B: Like see I, I interpret it differently. The way I think about this is, you know, it wasn't that treatment as usual was causing increases in craving and negative affect. You know, that that's a probably a phenomenon that was happening anyway and that treatment just probably wasn't managing it as well. Now these are folks in the first, they had to be in the first year of a current recovery attempt but many were just sort of initiating recovery attempt. And so it's important to note that in very early recovery from addiction, often we do see increase negative affect and craving. We would expect that because for one folks have probably relied on alcohol and other drugs to cope with negative affect. And now they don't have that suddenly like that's not a tool, that's not something they can use because you know, now I've announced in its goal and are working towards.
So you know, and of course we would also expect to see increases in Craving at that time as well. So. So, you know, it sort of makes sense. They're going up. What this probably speaks more to is the capacity of HIV by feedback.
[00:21:58] Speaker A: Yes.
[00:21:58] Speaker B: To help people manage that stuff. So it's not like the message isn't like treatment as usual, you know, we should give up. And in fact, it's iatrogenic, you know, it's causing more problems than it's solving. Like, I don't think that's what's happening. I think we're just seeing that, you know, that probably the experimental group, had they not have gotten HIV biofeedback, probably would have shown a similar trend. Yeah, but because, you know, the HIV biofeedback was helping them manage that negative effect, we were seeing reductions.
[00:22:29] Speaker A: Yeah. Well, what do you think? Just, you know, and I, I always want to make sure. Speculation here because, because I know this. If we would just, you know, just again, total speculation, play this out for 12, 16, 6 months, would you.
Would you just kind of speculate? Not because we don't have the data to show this, but would you kind of see, I would say cravings with the control group eventually start to a negative affect trend downwards, or we're in a positive direction for these two negative outcomes.
But I would assume that since the HRV biofeedback would just keep being kind of ahead of that curve for people, again, knowing that we're speculating here that it would just kind of maybe accelerate the recovery, if that's not too much of a powerful speculation on my part.
[00:23:27] Speaker B: You highlight an important point here. And we know on average people in the first year recovery from addiction, often we do see increase in craving and negative affect early on, but eventually that it gets better. It ameliorates. Right. With time, as you would expect. You know, like, yes, things settle down. Like, you know, folks like start feeling better, you know, they're through, you know, you know, acute and chronic withdrawal syndrome they may be experiencing, they may be getting, you know, dialed into treatment. And, you know, their sort of social and psychosocial world is stabilizing. Right. We see reductions in negative affect and craving, to be sure.
Now the question is sort of, and we didn't have follow up in this phase two trial.
It's a phase two trial and that's something we usually say for phase three.
So we don't know whether this HIV biofeedback, if those gains would be sustained.
The way I think about this is if this is a tool that maybe helps people ride out the early, early, you know, phase of recovery when Negative affect and craving can be a potent trigger for relapse.
If it could help folks get over that hump, you know, maybe they've got a greater probability of getting to that six month mark, three to six month mark where they do start naturally feeling better. So in that way, you know, it could be bridging people.
That's an empirical question for a phase three trial. You know we, we need to, we need to ask that question and have follow up period to really see if the benefits are sustained. But that's what I suspect is, you know, there's going to be potential like long term benefit. If there is long term benefit, it's probably because even if people stop doing the biofeedback after eight weeks, that's going to help bridge a lot of folks. Not everybody, but a lot of folks.
[00:25:23] Speaker A: A lot of folks, yeah. Yeah. Because like you said, such a vulnerable time for folks. I wonder if you saw maybe, you know, how maybe you track this. Maybe you did, but like were you tracking sort of hrv, RMSSD or high frequency? Were you, were you kind of looking at, you know, I don't know if the control group, probably not since they weren't on a device, but I wonder if you got anything from the experimental group. Did you see sort of positive trends in the, the HRV data, even their biofeedback data? Did you see more low frequency over time? Did you see any of that, you know, in, in the research and data collection?
[00:26:03] Speaker B: Yeah, so that, that's, you're speaking to some ongoing work we're doing. So we did collect from the ECG devices. We were able to collect interbeat interval data and calculate heart rate variability statistics for the experimental group. But we didn't have the controls where any kind of device.
Again we were weighing burden with you know, like benefit and, and we just said, you know what, like for phase two, like what we care most, the primary outcomes are really substance use and negative affect.
[00:26:40] Speaker A: Absolutely.
[00:26:41] Speaker B: Craving, you know, they were the big ticket items we're interested in and yet we had access to that physiology data in the experimental group and so we're starting to analyze that now. And, and generally yeah we, we have, we are seeing our preliminary analyses as you would expect in HRV in that group. Unfortunately we don't have the comparator so we're going to be a bit limited in what we can sort of the story we're able to tell there.
But we do plan to publish those findings. One of the things we're sort of interested in is like is it necessary to Experience chronic changes in HRV to experience clinical benefit. Yeah, that's sort of an empirical question that the field has been asking. And because it seems like initially in the early days of HIV biofeedback, it was thought that was probably the mechanism you increase HIV that leads to secondary benefits in mental health and well being.
But we've seen in a lot of our studies that even though folks don't experience sometimes chronic increases in hiv, they still see reductions in anxiety, depression, stress, craving. And so it well may be that there's something more happening acutely in the moment when people are practicing that is affecting physiological change in the moment that's having an effect on the brain, that's having a benefit, a curative, a benefit for the patient of the participant that might not necessarily translate into resting changes in hiv. Right. So that's a question we're trying to tease out. We'll be a start to get to that with this data.
[00:28:17] Speaker A: Well, and obviously I'm sure you would love to wave of magic wand and do this as well. It would be great to have like a few months while they were still using two like that. That would be like. I'd love to see that data because you know that that's the real baseline in many ways that would be, and I know that's, that's a magic wand sort of data set that would be very, very, very challenging possibly to get to with folks. But that, that would be just to study that transition because I'm always fascinated. And if you have any thoughts on this, like the difference between, especially with biofeedback and HRV tracking, are we measuring states or traits like, you know, because it takes a while. Neuroplasticity is an immune, just a beautiful miracle of the human nervous system. And yet it's not especially, you know, once you, you get above the age of 25, you know, it's, it's not a very fast thing that happens as well. So sometimes like HRV biofeedback studies that only go four weeks, it's like, you know, is there, are we seeing any neurological changes in that time, you know, with that? So that's always been something I've been fascinated with. Are we studying enough to see real changes in the nervous system? And I think, you know, having a state of relaxation and emotional regulation is a powerful tool in and of itself.
[00:29:43] Speaker B: Absolutely.
[00:29:44] Speaker A: It's just interesting that state or trait piece. I just kind of wonder if you had any, any, any thoughts of, of, of of that with these folks that again are in a very vulnerable kind of position in life, in their recovery.
[00:29:58] Speaker B: And this is, this is a question, you know, I really want to tease out in future studies is like, you know, not, not just sort of how much people, you know, I want to know how much people need to be practicing each day to get benefit because that obviously informs clinical guidelines and the less the better, right? The more likely people are, the less they have to do, the more likely they are to practice. So if I can tell people just do 12 minutes a day, that's going to be enough. Like that's much better than just saying, well, I'm going to have everyone do 40 minutes a day knowing they'll never do that. And they might just not even try.
[00:30:29] Speaker A: Because the world, Dr. Eddy, is waiting for that result. So.
[00:30:34] Speaker B: Yeah, but I want to know sort of like also sort of of, you know, in terms of sort of sustained practice, like, you know, for, for addiction especially because that's, that's my area of focus. Like, you know, is it enough for folks to do an eight week burst of HIV biofeedback? And that's going to, you know, on average bridge folks to their next phase of recovery. And you know, and maybe then after that they just sort of use it sporadically because, you know, once you learn this breathing practice with biofeedback, most folks after a few weeks internalize it and they can, can go into the breathing practice without any kind of equipment. And so in that way it could be a potent tool that people carry with them through the life course at no cost, with no, no downside, no, no bad side effects, no contraindications.
So in that way, you know, maybe folks aren't practicing every day, but it's still a tool they have in their toolbox to manage acute stresses when they arise. That could still be a useful tool for people on their long term recovery journey. Maybe people just can stop practicing altogether and there's still benefit that they've been bridged. Maybe people actually do need to keep doing it regularly to get sustained benefit. That's the question we need to, we need to address in future studies. We don't know.
[00:31:50] Speaker A: Yeah, I, I'm curious.
One, any findings? We haven't talked about that, that we should. And two, I, I don't know if there was any kind of qualitative data of, you know, what, what you heard back. I mean, obviously you were collecting data on affect and cravings means, but just kind of anything, maybe qualitative that, you know, came up along the way from, from the experimental group as well.
[00:32:15] Speaker B: Yeah, so, so a couple of things.
You know, firstly. Yeah, there was another key finding we haven't talked about yet. And that was that we saw significant reductions in substance use.
[00:32:26] Speaker A: Yeah, yeah, I probably should have led with that one.
[00:32:30] Speaker B: Yeah, well, we were getting that. We're getting that.
And, and you know, here's the interesting thing. Like, you know, I told, I mentioned that we asked folks to do about 15 minutes of practice a day. That was our goal. Like only about like 25% of the sample did that 50% of the time.
[00:32:49] Speaker A: Yeah.
[00:32:49] Speaker B: Right. And so like most folks were sort of like under threshold for dosing.
[00:32:56] Speaker A: Yeah.
[00:32:56] Speaker B: And what we saw, a 64% reduction in substance use in the experimental group. Like non trivial large effect size reduction in the probability of day level substance use, any alcohol or other drug.
And so then, you know, pair those two findings together. Like, folks weren't practicing as much as we asked them to, as much as we thought they needed to, and yet we were seeing like these significant reductions in craving, negative affecting and substance use.
So what that makes me think is that it wasn't so much how much people were practicing, it's when they were practicing.
[00:33:35] Speaker A: Yeah.
[00:33:36] Speaker B: How they were using it. And what we were able to explore because we had ema ecologically momentary assessed data, we were actually able to look at these more granular day level associations between craving and substance use. And so we were actually able to determine and our statistical models that the people in the, the experimental group getting biofeedback, they did experience craving, but they were significantly less likely to have substance use later in that day when they had clothing earlier in the day than the control group.
[00:34:09] Speaker A: That's awesome.
[00:34:09] Speaker B: So what we, we were able to infer from that is that folks are using, they were using the biofeedback in the moment when craving was arising, which is kind of what we told them to do. So that's good.
But they were using it strategically and it was helping them probably ride out those moments of craving and getting through the day without picking up alcohol or other drugs, whereas the control group didn't have that in the moment tool. Now maybe they were getting some in the moment tools from, you know, if they were doing cognitive behavioral therapy with their therapist. But not everybody was. We weren't controlling for that.
[00:34:43] Speaker A: Yeah.
[00:34:44] Speaker B: So, you know, it seemed like what really mattered was it was, you know, that people were using it in the moment moment and it was helping bridge them. Which is really one of our hypotheses leading into this study that we speculated people would be using it in the moment and that I place that hypothesis on my previous studies where I'd gotten feedback from participants even though we weren't really assessing that and they were sort of old school studies where we were just doing pre and post questionnaires but participants were telling me when I meet with them each week to do biofeedback with them. They were telling me like, you know, I'm using this in the moment. Like I, you know, I, I, I noticed, I felt like I was about to have a panic attack and I, I did a few minutes of breathing and it stopped, it stopped symptoms and I, I felt like I had to control. So I was already thinking like people are probably, this is probably how people are going to use, use this and have drive benefit. And so that, that, that played out. And then in, in terms of the qualitative findings, we did do some focus groups. So with, with participants, with a small group of the participants, about 10 folks, two focus groups and you know, we asked people like, you know, what did you think? Like did you like the device? Did you not like it? You know, was there things about it, you know, that you like that were annoying, that you would change? And we just wanted to like, tell us what you think, you know, like and did it help? Did you feel like it helped?
[00:36:11] Speaker A: Yeah.
[00:36:11] Speaker B: And by the way, were the prompts from the device helpful or were they annoying? Yeah, like, I mean, you know, for me I just wanted to know like, I don't know, like financial investment in like this.
[00:36:20] Speaker A: Yeah.
[00:36:21] Speaker B: Company or you know, like the Leaf device. You know, like I think it's a great product but you know, like, you know, I, I just want to know like, you know what from a subjective point of view, from a participant point of view, I mean the data look great, right? But like what do they think? And they told us that, you know, one, you know, they, they like the device, they like, you know, they like the feedback that they really, really felt that the just in time prompts helped them increase their own sort of self awareness of their stress and to sort of also start to see how much they experience stress in their body. So it was really like in a way this is not the goal of the device or you know, we weren't, this wasn't sort of part of the plan, therapeutic plan, but sort of a side benefit was it clearly seemed to be helping people increase their self awareness of risking moments and, and also of course was giving them something to do with that risk right in the moment. So it's a double win potentially. And so generally the feedback was super positive. Now take it. With a pinch of salt. Like, the people who agree to be in these focus groups after a study tend to be the folks who either really like the intervention or really.
And people who are like so, so about the mention usually are like, like, no, it's all right. You know, I don't feel like I had that much to say about it.
[00:37:40] Speaker A: Yeah.
[00:37:40] Speaker B: So, you know, and, and usually excuse towards people who have nice things to say.
[00:37:45] Speaker A: Yes.
[00:37:46] Speaker B: You know, take, take it for what it is. Like, there was obviously like, there were pro. Certainly people who probably didn't have that experience. Right.
So, so there's that. But overwhelmingly the, the feedback was like, yeah, this is great. It was comfortable to wear. Like, you know, there were some issues with like, like, you know, charging a few people noted like some pretty small stuff like in the greater scheme of things kind of stuff we see with digital therapeutics.
[00:38:12] Speaker A: Right.
[00:38:13] Speaker B: More broadly.
But the feedback was overwhelmingly positive. We want to publish those findings as well.
[00:38:18] Speaker A: That's awesome. Well, that kind of leads me here to my, my, my last question of.
You know, we, we talked a little bit before we hit started. Funding for research in the United States is a very fraught topic.
So without getting too depressed between the two of us, where would. Let's just say funding's going to happen because this research needs to continue.
You know, I'm sure all of our listeners would agree to that.
Where do you want to take this? What are some of the next questions or study designs that. But you mentioned a few of them. You know, are we going to go to, to the, you know, stage three? Like, you know, if funding is not an issue, which I know that's. We're going to fantasy land right now. But like, what, what would, what are, what, what are your hope for next steps?
[00:39:14] Speaker B: Yeah, yeah, look. Yeah, funding's always, Funding's always the thing, isn't it? You know, it's always a challenge. I mean, we're so fortunate in the United States to have a national institution.
I mean, no other country really has that kind of like the power and the infrastructure to support research and the way. So we are well situated. You know, even though like, you know, there is. There are challenging times, you know, with federal funding and sort of we're in one now. You know, the NIH is still a powerful force for good.
And they funded the phase two trial. The National Institute of Drug Abuse funded that. That study.
And that was funded through what we call. It was called an R21 mechanism, which is really a pilot phase two.
[00:40:00] Speaker A: Grant.
[00:40:01] Speaker B: Mechanism designed to collect preliminary data that's the kind of grant you apply for. If you don't have preliminary data, you think you've got a good idea, an interesting intervention and there's a pretty good theoretical basis for it. You can like sell to, you know, pitch to the reviewers and, and you know, get their buy in and you can get a little bit of seed money to do that preliminary trial. And then if that preliminary trial shows positive results, if there's a signal there, a potential benefit, then you go back to, you know, and say, all right, look, there's clearly something going on here, like some good. Yes, this is worth looking into more. This is worth, you know, funding a phase three trial. And that's where we're at now. So we're going back to NIDA now with a new application for phase three funding. We're saying, look, you know, the data look really good, you know, published the results in JAMA Psychiatry and you know, it's exciting. But more, you know, of course, you know, we, more data is needed, more research like before we can say with conviction that this is, has efficacy and this is, should be something, you know, physicians and clinicians recommend their patients utilize.
And so, you know, so that, that, that's under review now and, and you know, with a bit of luck, you know, that gets funded and we will, you know, be doing the phase three trial perhaps starting sometime next year.
[00:41:23] Speaker A: I, my fingers, my toes, everything is crossed because like I said, you see some, even like some papers that I like that just kind of fizzle out and this was, this has caused really great waves in kind of that secondary market it for research and getting the word out there, like just, I don't know, it's, it's a beautiful study. Like, you know, I don't use that word a ton when I, I read this and I was just so thrilled that I knew the primary author and then I have a chance to do this interview with you. So hopefully we can help be a little bit of that secondary push to get that, this out in front of people. Because I, yeah, like you said, like, like having done work around substance use in a couple different settings, like it is such a vulnerable time and relapse, especially with things like opiates and fentanyl. Like, you know, even with alcohol and other things it can be life threatening if not life ending.
[00:42:23] Speaker B: That's life and death.
[00:42:24] Speaker A: So that, that support and you know, during that vulnerable time I just think could not only improve our outcomes but potentially save lives as well. Which is just so exciting to see this in practice in that way.
[00:42:39] Speaker B: Absolutely. Absolutely. And look, more research is needed.
But at this point, the recommendation is based on what we're seeing.
There seems to be benefit here.
And so because this intervention doesn't have any adverse side effects, it doesn't have any contraindications which mean it doesn't mix poorly with other treatments. Yes, medications, it's relatively safe, we think, you know, from previous trials.
You know, this is something, it's probably some. Something, you know, for folks in early recovery from addiction. You know, there is potential benefit, you know, to trying this out now. You know, I wouldn't say like, you know, don't. I'd say keep doing the other stuff you're doing too. You know, I wouldn't, you know, the data.
[00:43:26] Speaker A: Sure, yeah.
[00:43:26] Speaker B: You know, in the phase three trial, we're actually going to have three conditions. So we'll have HIV B, biofeedback alone, CBT alone, and HIV biofeedback with cbt. What we really want to see is like, does CBT and HIV biofeedback together produce at a benefit or you know, perhaps is like HIV biofeedback alone enough? Like maybe, I suspect not. Like, I think there's probably like, you know, a wraparound treatment like CBT is really going to confer a lot of benefit. It. And I don't think HIV biofeedback could replace that. But again, it's a question.
We have to wait for the data to tell us.
We can have hypotheses, we should have hypotheses, but we can't know.
But at this point, the data look, you know, really promising. And because there's really no downside to HIV biofeedback practice, you know, is something I would recommend, you know, people look at if they want to supplement what they're doing currently.
[00:44:28] Speaker A: Yep. Well, and like I said, without the danger.
I'm sure you see this too. It doesn't work for nothing. Works for everybody.
We have not found that intervention that works for everybody. So at a very affordable price point for the long term benefits is can you integrate HRV biofeedback? And, you know, you may have some people who do it once and just don't ever do it again. You may, but, you know, if there's a, a 60, 70% uptake of people using it, especially again, and I think also positioning it is, hey, let's get through this vulnerable time. Here's another tool in your recovery, you know, that's helping, you know, give them a little psycho education on their nervous system, you know, create, you know, lower cravings and, you know, so many relapses, too.
There's a lot of complexity around this. But a bad mood, you know, whether you're tired, grouchy, hungry, like, all those triggers, like you're addressing both the craving side and some of those, you know, other, you know, states, if you will, that can lead to relapse. And, you know, a tool that does both of those, you know, like I said, I, I can't think of better homework.
They can still journal because we always like to get people, but, you know, you know, I can't think of better homework to give people. And this study just really, I think, opens that door to giving us the data. We need to really advocate that this for programs to offer this as at least an option or part of their programming for folks.
[00:46:03] Speaker B: Yeah, yeah.
[00:46:05] Speaker A: Dr. David Eddy, you gave the world a huge gift here. If you talk to your co authors, please pass on the thanks from us HRV nerds out here in the world that this research.
So we'll put a link to the article in the show, notes for everybody, as well as information about you as well. And like I said, if you're interested in this conversation, going back to our previous conversation, I know we do a deeper dive into, you know, some of your work specifically around that as well. So a great compliment to that. And you got to promise me, when stage three, you start getting some good data and good conclusions from that, I'm sure me and my audience cannot wait to have that conversation.
[00:46:53] Speaker B: I'll be back.
[00:46:55] Speaker A: All right. Thank you, my friend. As always, you can find show notes information links at optimalhrv. Com. Thank you everybody, and have a wonderful week.
